Supply Chain Integrity Featured Articles
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The Supply Chain Of The Future: A Strategic View
8/26/2014
Evolutionary theory teaches us it is neither the strongest nor the most intelligent of the species that survives. It is the one that is the most adaptable to change. Peter Bigelow, president of xcell Strategic Consulting, likes to mention this quote, widely attributed to Charles Darwin, when opening presentations on the future of the pharmaceutical supply chain. Ingredient suppliers, manufacturers, quality standards and audits, and logistics are just a few areas where we can expect to see many changes going forward. Adapting to these changes will be critical to everyone involved in the process, and in ensuring medicines are delivered to patients safely and effectively.
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API Manufacturing: Alive And Well In The U.S.
6/25/2013
Dr. Stephen Munk, president and CEO of API manufacturer Ash Stevens, had been taking Lipitor for years. But when his insurance company mandated a generic version of the drug, he was switched to one produced by Ranbaxy Laboratories, a manufacturer based in India. In November Munk learned that glass shards were found in the product. “I went to my pharmacy and told them I wasn’t happy about glass particles showing up in a drug I was taking,” he says. “They told me the FDA had not issued any guidance on it, so don’t worry about it. The entire incident was just further proof to me that U.S. API manufacturing was poised for significant growth.”
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Quality By Design, Should Pharma & Biotech Suppliers Be Ready?
1/31/2013
Quality by design, oh my … is it salvation or mere vexation for manufacturing and other suppliers to pharma and biotech companies — or something else entirely?
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Save Time, Money, And Improve Supply Chain Management With E-Procurement
12/7/2011
If your staff is using a manual, paper-based procurement system, they probably search through stacks of catalogs and visit multiple websites for the products they need. By Karl Schmieder, contributing editor
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Refinement Of Industry Guidance Promotes Harmonization Of Good Distribution Practices ... But Gaps Remain
11/1/2011
It is an exciting time for those with an interest in the pharma cold chain. While change may cause uncertainty, for those engaged in the heavily regulated healthcare industry, the ongoing refinement of guidance further clarifies the regulatory requirements for the storage and distribution of temperature-sensitive products. By Chris Fore
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5 Key Questions & Answers Regarding Pharmacovigilance
9/29/2011
A Q&A with Sanket Agrawal, executive director, global regulatory affairs and safety, at Amgen, and Nagaraja Srivatsan, senior VP, head of life sciences, North America, Cognizant Technology Solutions.
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The Challenges Of A Supply Chain Manager In An Evolving Clinical Landscape
9/7/2011
Effectively planning and executing a successful clinical supply chain is a complex task inundated with key decision points that have significant consequences for a clinical trial.
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Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain
With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.
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Pain In The Chain Survey: Time To Capitalize On Untapped Opportunities
UPS has released its 7th annual UPS Pain in the (Supply) Chain Survey of executives in the pharma, biopharma, and med device industries. While this latest version of the survey shows executives still have concerns over the economy, rising costs, and regulatory challenges, there are opportunities companies can capitalize on to help move the industry forward.
On the positive side, the growth of the global population and the middle class, along with a rise in the median age has created a growing demand for healthcare services. The report notes in order to capitalize on these new opportunities, companies will need to move quickly to make strategic changes to their supply chains. Unfortunately, supply chain change seems to come slowly, and in the current risk-inherent environment, may be impeding growth in the industry.
While some companies are reacting to emerging opportunities by transforming their supply chains, the report states the winners in tomorrow's healthcare marketplace will be those companies that make their supply chains more flexible and efficient, and begin making those changes as soon as possible. Those that don’t may be taking on the greatest risk of all.
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UPS Worldport: A Transportation And Logistics Modern Marvel
One of the joys of working in media is the amount of travel I get to do as part of the job. While boarding planes and sitting in airports can become exhausting and tedious at times, I do get to visit some pretty amazing places that I otherwise would not have the opportunity to access. Visits to major cities like Boston, Chicago, and NYC are always enjoyable, as are visits to landmark places such as the New York Stock Exchange. Since I have been involved in the life sciences space, I have also gotten to visit some pretty memorable manufacturing facilities such as CMC Biologics, Therapure Biopharma, and Gallus Biopharmaceuticals.
Recently I had the privilege of attending a tour of the enormous UPS Worldport facility in Louisville, KY. To say this hub is incredible would be an understatement. The place is more amazing than Disney World, and should probably be considered as a contender for the eighth wonder of the modern world.